1. Pharmaceuticals and Senate Bill 1757 Tom Y. Harrigan, P.E. TCEQ Water Quality Division Wastewater Permitting Section 512/239-4671

2. Overview What are Pharmaceuticals? What is the Problem? Sources and Fate in Wastewater (WW) Occurrence in Water – USA and TX Ecological/Health Impacts Current Standards Senate Bill 1757 Project Intent and Objectives Tasks for TCEQ Study Team Pharmaceutical Disposal Advisory Group (PDAG)

3. What are Pharmaceuticals? Chemical or biological substances taken for the purpose of preventing, curing or reducing the symptoms of an illness or medical condition. Prescription medications Over-the-counter medications Veterinary medications Controlled substances Examples: Antibiotics, anti-inflammatory, anti-depressants, Anti-diabetics, cardiovascular drugs, Reproductive hormones, thyroid hormones….

4. Major Sources of Pharmaceuticals in Wastewater Intentional disposal of unused drugs (flushed down toilet or sink) Pharmaceuticals enter wastewater stream (WWTP or septic systems) Medicines consumed & not completely metabolized (or metabolized into other forms) Major: Excretion Minor: Sweat & vomit

5. Fate of Pharmaceuticals in WW Conventional WWTPs not designed to remove pharmaceuticals (but they tend to remove some). Some information exists on the removal of pharmaceuticals from WWTPs under innovative treatment technologies. Eg. Membrane filtration, reverse osmosis, ozone, UV, and combinations Depending on treatment used, removal efficiencies range 1%-100%. Generally, innovative treatments remove more pharmaceuticals. Limited number of WWTPs employ innovative treatment technologies in Texas.

6. Fate of Pharmaceuticals in WW Some pharmaceuticals are removed more easily than others under the same treatment processes. Eg: Complete elimination of 17-ethinylestradiol and others, yet only 20-60% removal efficiency for others (incl. ibuprofen) and carbamazepine was not removed at all (Carballa et al., 2007). Consequently, various pharmaceuticals may remain in water at variable concentrations after WW treatment

7. Fate of Pharmaceuticals in WW → Therefore, pharmaceuticals could be discharged to surface waters (rivers, lakes) that become our drinking water sources. → Aquatic organisms may also be exposed DWTPs have similar issues as WWTPs with removing pharmaceuticals.

8. Occurrence Data Significant amounts of research (and media attention) around the world studying the occurrence of pharmaceuticals in water In USA, significant national studies were undertaken by USGS 1999-2002, plus many private and government studies since then. Studies confirmed pharmaceuticals (& other emerging contaminants) do occur in US waters (at low concentrations).

9. Occurrence Data USGS National Stream Reconnaissance 1999/2000: 139 streams tested for ‘emerging contaminants’; 30 States 50% streams contained 7 or more of the chemicals Pharmaceuticals acetaminophen and codeine were found in 24% and 11% of samples, respectively. Steroids and hormones were also commonly found in surface waters, with 17-ethynyl estradiol (estrogen hormone) in 16% of samples analyzed. Antibiotics and antimicrobials were found in over 10% of samples analyzed. See Kolpin et. al. 2002.

10. Occurrence Data - Texas Some pharmaceutical occurrence data exist in TX waters: South-central Texas WWTP influent /effluent study: most pharmaceuticals were completely removed (the exception of carbamazepine, an anti-epileptic) as a result of WW treatment. None detected in treated drinking water supply. Also found that a hospital contributed 12 emerging contaminants to the WWTP. North Texas DWTP raw/treated study: A number of pharmaceuticals detected in raw water entering DW treatment plants. However, only one pharmaceutical (an anti-anxiety drug) was found above detection limits in the treated (finished) drinking water.

11. Ecological Impacts Ecological impacts of exposure to pharmaceuticals have been observed. Well documented study is the feminization of fish: Chronic exposure of fathead minnow to low concentrations of synthetic estrogen led to feminization of fish population 7-year study resulted in near extinction of the fish species in Canadian lake

12. Ecological Impacts Several other ecological impacts observed: Reduced predator behaviors Developmental delays (eg. tadpoles exposed to prozac that don’t grow limbs) These impacts may inhibit species survival Note that aquatic life are continuously exposed.

13. Human-Health Impacts No evidence of adverse health effects to humans Studies show negligible risk to humans associated with the exposure to pharmaceuticals via drinking water (Schwab et al., 2005). However, knowledge gaps exist: Lack of information about the effect of long-term exposure to low concentrations of pharmaceuticals in water supplies on human health Questions remain about the combined effects of multiple pharmaceuticals on human-health Concerns of antibiotic-resistance in humans

14. Applicable Water Standards ‘Emerging contaminants’ are currently outside the scope of the TCEQ's Drinking Water and Wastewater regulatory authority. Drinking Water: No pharmaceuticals listed in the Primary or Secondary National Drinking Water Regulations. However, 10 pharmaceuticals are listed on the Contaminant Candidate List 3 (CCL3) – used by EPA to help determine if chemicals should be regulated in future.

15. Wastewater Regulations Effluent analyses for approx 150 pollutants are required during the permitting process for WW treatment facilities with a permitted/proposed flow of ≥1 MGD, or facilities with an approved pretreatment program. A screening procedure is performed That may result in effluent limits and/or monitoring requirements for pollutants that exceed the criteria (found in 30 TAC Chapter 307). A few of these pollutants are used in pharmaceutical manufacturing but are not pharmaceuticals themselves.

16. Senate Bill 1757 Project Passed in 81 st Legislative Session, 2009 TCEQ shall study and make recommendations regarding the methods to be used by consumers, health care providers, and others for disposing of unused pharmaceuticals so that they do not enter a wastewater system. Report due to legislature December 1, 2010

17. Pharmaceutical Removal/Reduction from WW PREVENTION APPROACH Prevent/reduce the amount entering to wastewater system Consider non-flush disposal options TWO APPROACHES TREATMENT APPROACH Remove the pharmaceuticals AFTER they’ve entered the wastewater system Requires improved WW treatment tech

18. General Intent of SB-1757 Intentional disposal of unused drugs (flushed down toilet or sink) FEWER pharmaceuticals enter wastewater stream Medicines consumed & not completely metabolized (or metabolized into other forms) Major: Excretion Minor: Sweat & vomit

19. Origins and Fate of PPCPs in the Environment (figure from EPA webpage)

20. Objectives Specifically, TCEQ shall consider: (1) the methods currently used in Texas (by consumers, health care providers, and others); (2) alternative methods used, including methods used in other states; and (3) the effects on public health and the environment of the various methods used for that purpose. (4) The report must also provide an analysis of the feasibility of implementing the recommended disposal methods on a statewide basis.

21. TCEQ Developed a Study Team: Elston Johnson (Public Drinking Water) Jessica Huybregts (Public Drinking Water) Thomas Harrigan (Water Quality) Eric Beller (Municipal Solid Waste) Clyde Bohmfalk (Water Quality Planning) Angela Curry (Toxicology) Shannon Herriott (Pollution Prevention & Ed.) Jeff Horvath (Strategic Planning) Daniel Ingersoll (Env. Law)

22. Intent of Advisory Group To provide a forum for TCEQ to gather appropriate and sufficient information to understand the: methods currently used in Texas to dispose of unused pharmaceuticals; amount (and type) of unused pharmaceuticals currently disposed of via various methods; factors driving disposal practices; regional differences in disposal practices; desires of consumers, the health-care industry and others for alternative disposal methods; and knowledge gaps.

23. Intent of Advisory Group To provide an opportunity for stakeholders to convey their experiences (good and bad) regarding the current methods of disposing of unused pharmaceuticals.

24. Suggested Stakeholders In conducting the study, the TCEQ may solicit input from: (1) the Health and Human Services Commission; (2) the Department of Public Safety of the State of Texas; (3) pharmaceutical manufacturers; (4) pharmacies; (5) health care providers, including home health care providers; (6) hospitals; (7) clinics; (8) long-term care facilities; (9) entities that engage in medical waste processing and handling; (10) solid waste management service providers; (11) local governments; (12) ranchers and farmers; (13) end users of medication; (14) water utilities and other water suppliers; (15) the United States Postal Service; (16) the United States Environmental Protection Agency; and (17) any other entity the commission considers necessary.

25. Advisory Group Meetings Monthly, January through June 2010. Next meeting on February 26 th. All meetings will be at TCEQ Austin office. LiveMeeting services will be provided at each meeting for anyone interested. Webpage lists upcoming meeting information, including dates, agendas and past meeting minutes. http://www.tceq.state.tx.us/permitting/water_supply/pdw/ pdagroup

26. Advisory Group Meeting Topics Each meeting will have a specific topic. Potentially: January: Define objectives and scope. February: Discussion of current disposal practices March: Complete discussion of current disposal options and introduce alternative disposal practices April: Discussion of alternative disposal practices May: Feasibility Considerations June: Summarize findings and final considerations.

27. Summary Pharmaceuticals are removed to varying degrees in wastewater treatment. Therefore it is possible for them to enter surface waters that become drinking water sources via discharge of treated effluent. TCEQ’s cross-discipline study team is working on a response to SB-1757, due Dec. 1st, 2010. SB-1757 addresses methods of disposing of unused pharmaceuticals so that they won’t enter a wastewater system. TCEQ developed the Pharmaceutical Disposal Advisory Group to help identify the current methods of disposing of unused pharmaceuticals and understand factors affecting disposal practices across Texas.

28. TCEQ Contacts Elston Johnson (Water Supply Division) E: eljohnso@tceq.state.tx.us P: 512-239-0990 Jessica Huybregts (Water Supply Division) E: jhuybreg@tceq.state.tx.us P: 512-239-4709 Thomas Harrigan (Water Quality Division) E: tharriga@tceq.state.tx.us P: 512-239-4521 Pharm. Disposal Advisory Group Webpage http://www.tceq.state.tx.us/permitting/water_supply/pdw/ pdagroup